Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients (AQUARIUS)

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00853827
First received: February 26, 2009
Last updated: September 12, 2013
Last verified: September 2013

February 26, 2009
September 12, 2013
March 2009
January 2013   (final data collection date for primary outcome measure)
Change in the progression of coronary atherosclerosis (defined as change from baseline in percent atheroma volume) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00853827 on ClinicalTrials.gov Archive Site
  • Change in normalized total atheroma volume as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients that demonstrate evidence of atheroma regression (defined as any reduction in percent atheroma volume from baseline) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Overall safety and tolerability of aliskiren compared to placebo following treatment duration [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Coronary Artery Disease (CAD)
  • Coronary Atherosclerosis
  • Drug: Placebo
    Placebo
  • Drug: Aliskiren
    300 mg
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Aliskiren 300 mg
    Intervention: Drug: Aliskiren
Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, Brunel P, Nicolaides M, Hsu A, Hu B, Fang H, Puri R, Uno K, Kataoka Y, Bash D, Nissen SE. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA. 2013 Sep 18;310(11):1135-44. doi: 10.1001/jama.2013.277169.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
613
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg.
  • Patients with or without current treatment for hypertension
  • Angiographic evidence of coronary artery disease
  • At least 2 qualifying Cardiovascular risk factors at Visit 1

Exclusion Criteria:

  • Baseline IVUS determined unacceptable
  • Patients requiring treatment with disallowed study medications
  • Patients with clinically significant heart disease
  • Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%
  • Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:

    • Angiotensin converting enzyme inhibitors
    • Angiotensin receptor blockers
    • aldosterone receptor blockers or a direct renin inhibitor.
  • Other conditions may apply
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Canada,   France,   Germany,   Hungary,   Italy,   Poland,   Spain
 
NCT00853827
CSPP100A2366, 2008-006447-40
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
The Cleveland Clinic
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Novartis
Novartis
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP